K213840 is an FDA 510(k) clearance for the MolecuLight I:X, a Autofluorescence Imaging Adjunct Tool For Wounds (Class II — Special Controls, product code QJF), submitted by Moleculight, Inc. (Toronto, CA). The FDA issued a Cleared decision on May 18, 2022, 160 days after receiving the submission on December 9, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4550.
| 510(k) Number | K213840 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 2021 |
| Decision Date | May 18, 2022 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QJF — Autofluorescence Imaging Adjunct Tool For Wounds |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4550 |
| Definition | An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis. |